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Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Shahzeer Karmali, University of Alberta
ClinicalTrials.gov Identifier:
NCT01025076
First received: December 2, 2009
Last updated: April 21, 2012
Last verified: April 2012
History of Changes
  Purpose

Executive Summary

Aims and Hypotheses of the Study:

The aim of the study will be to evaluate the safety, effectiveness and early outcome of the StomaphyX procedure for reducing the enlarged gastric pouch and stoma in post-bariatric patients. The study will test a hypothesis that the StomaphyX procedure will be effective in promoting the loss of regained weight, reducing the risk for comorbidities and improving patients' quality of life.

Type of Study: Prospective non-randomized Study Duration: 12 months Number of Patients: 20

Inclusion Criteria:

18-70 years of age, BMI ≥ 35, ≥ 2 years after primary Roux-en-Y gastric bypass with evidence of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or fluoroscopy. Pts also demonstrate a weight regain of 15% of excess body weight loss.

Exclusion Criteria:

Esophageal stricture, or any anatomic conditions that preclude passage of transoral endoluminal instruments, has another causal factor for weight regain other than stoma or pouch dilatation, portal hypertension, coagulation disorders or chronic use of anticoagulants, any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient.

Intervention Treatment: Creation of multiple full-thickness plications within the gastric pouch using the StomaphyX device (EndoGastric Solutions, Inc., Redmond, WA, USA)

Evaluation Criteria Primary Outcome: Change in body weight at 6 and 12 months Secondary Outcome: Gastric pouch volume assessment, stoma diameter determination, quality of life scores, waist circumference, co-morbidity resolution Effectiveness and Safety Assessment Clinical: Weight, height, waist circumference quality of life questionnaires (Impact of Weight QOL-Lite, Eating and Weight Patterns, Three-factor Eating, Emotional Eating Scale, GI QoL, GSRS and/or PGWB) Anatomical: Upper GI endoscopy, computed tomography or barium radiography Biochemical: Blood and urine tests (glucose, cholesterol, triglyceride, HDL, LDL, uric acid) Safety: Adverse events, complications, co-morbidities, hospital stay


Condition Intervention Phase
Morbid Obesity
 Device: StomaphyX
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Primary Outcome: Change in body weight; Secondary Outcome: Gastric pouch volume assessment, stoma diameter determination, quality of life scores, waist circumference, co-morbidity resolution [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: StomaphyX
    StomaphyX with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) is a transoral incisionless fastening device that allows for GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-70 years
  • BMI 35 or greater with one or more comorbidities
  • At least 2 years post-Roux-en-Y gastric bypass surgery
  • At enrollment, has regained at least 15% of excess body weight loss
  • Enlarged Stoma Diameter
  • Enlarged gastric pouch
  • Completed successful nutritional screening and compliant with nutritional programs
  • Completed successful cardiopulmonary evaluation
  • Patient willing to cooperate with follow-up assessment tests
  • Signed informed consent

Exclusion Criteria:

  • Esophageal stricture or any anatomic conditions that preclude passage of transoral endoluminal instruments
  • Has another causal factor for weight regain other than stoma or pouch dilatation such as non compliant with nutritional and exercise programs
  • Portal hypertension
  • Coagulation disorders or chronic use of anticoagulants
  • Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025076

Locations
Canada, Alberta
CAMIS, Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Sponsors and Collaborators
University of Alberta
Alberta Health Services
  More Information

Publications:

Responsible Party: Shahzeer Karmali, BSc, MD, FRCSC, University of Alberta
ClinicalTrials.gov Identifier: NCT01025076     History of Changes
Other Study ID Numbers: Pro00008913
Study First Received: December 2, 2009
Last Updated: April 21, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Enlarged gastric pouch and stoma
Post bariatric surgery

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013